Parkinson's DiseaseNucleiparkNCT01085253
Nucleipark:High Field MR Imaging (7T and 3T) of the Brainstem, the Deep Nuclei and Their Connections in the Parkinsonian Syndromes. Applications to Prognosis, Pathophysiology and Improvement of Therapeutic Strategies
An observational study of Parkinson's Disease and MRI, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
To date except for the larger striato-pallidal complex, there are no reliable imaging markers of small deep nuclei. Major improvement of the spatial resolution resulting from the use of ultra-high field MRI systems offers new perspectives of imaging of these deep structures. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, MRI
- What is being tested?
- 3T and 7T MR imaging
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 6 Apr 2010to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: parkinson's disease (PD) supranuclear palsy (PSP) controls
Who may be able to join
- PD according to the UK brain bank diagnosis criteria
- PSP according to the NINDS diagnosis criteria
Who cannot join
- contra indication to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: High Field MR Imaging (7T and 3T) of the Brainstem, the Deep Nuclei and Their Connections in the Parkinsonian Syndromes. Applications to Prognosis, Pathophysiology and Improvement of Therapeutic Strategies
To date except for the larger striato-pallidal complex, there are no reliable imaging markers of small deep nuclei. Major improvement of the spatial resolution resulting from the use of ultra-high field MRI systems offers new perspectives of imaging of these deep structures.
We will use the new contrast mechanisms available in data acquired with ultra-high field MR systems (7T) as well as the most recent high angular diffusion imaging techniques in order to characterize the cytoarchitectonics of the deep brain structures and brainstem lesions in parkinsonian syndromes (with special interest in substantia nigra (SN) pathology and nigro-striatal fiber pathways; subthalamic nucleus (STN), red nucleus (RN), oculomotor structures (involved in PSP); pedonculo-pontine nucleus (involved in gait and posture control disorders) and the locus sub-coeruleus area (implicated in sleep disorders) The optimized MR sequences at 7T will be adapted and validated at 3T (on a more clinically oriented MRI approach).
The clinical goal of the project (via the characterization of deep brain structures) is the detection of new neuroimaging markers of neuronal lesions in PD. These biomarkers will be used to create a diagnostic tool at early stage of the disease that could be correlated to clinical signs such as gait disorders and help to identify predictive factors. In addition, this could contribute to establish an adequate therapeutic strategy (as for example with deep brain stimulation).
Read the detailed description
This project will be divided into several methodological steps. First, we will establish an imaging protocol using high field MR systems (7T) to deliver high resolution data. The new T1/T2-star contrasts mechanisms observed in high field data will make possible the segmentation of the central structures, more specifically those deeply located in the brainstem, the pons and the mesencephalon that are involved in Parkinsonian syndromes. Second, we will characterize the cytarchitectony of the deep structures and the anatomical connectivity involved in the Parkinsonian syndromes using high angular resolution diffusion imaging (HARDI). The local information about the organization of the tissue coming from the HARDI data will be used to subdivide the deep structures into smaller nuclei. We will also use the HARDI data to infer the connectivity of these structures, employing probabilistic tractography algorithms more efficient to detect the smallest bundles. Such techniques have never been used for Parkinsonian syndrome, and may highlight structural differences inside deep nuclei that could not be observed when performing statistics on the entire structure. Third, preclinical studies will be performed in order to tackle the best spatial and angular resolutions and to build an atlas of the brainstem that will help understanding its structural organization. Clinical acquisitions will be done to acquire two databases of healthy volunteers and patients suffering from Parkinsons disease and progressive supranuclear palsy. Fourth, we will develop a statistical tool for isolating the biomarkers of the Parkinsonian syndrome and to create a diagnosis tool of the pathology, relying on robust bootstrapping techniques. The markers will stem from comparisons between populations using the various informations available. Expected results In this project, we will develop ultra high field techniques that will allow us to investigate the characteristics of the brainstem structures and of the central deep nuclei in normal subjects and in parkinsonian syndromes. The findings obtained with these image innovation techniques will help to overcome the present technical difficulties and limits of 1.5 and 3T MRI as some of the methods will be transferred to the routine machines and results will be compared to the images obtained on 3T MRI, in order to make new diagnosis tools available, in clinical research or clinical practice. The ultimate goal is to improve the accuracy of diagnosis of various parkinsonian syndromes at a early stage, to detect at a pre-clinical stage abnormalities that may reflect the underlying anatomical lesions, to improve the accuracy of neurosurgical targeting for deep brain stimulation, to detect imaging markers that may be useful biomarkers of the progression of the disease in neuroprotective therapy.
- Conditions
- Parkinson's Disease, MRI
- Being tested
- 3T and 7T MR imaging
- Keywords
- Parkinson's, supranuclear palsy, substantia nigra, sub thalamic nucleus, MRI
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3T and 7T MR imagingOther
all patients and controls will be explored using a 3T and 7T MR imaging
| Study group | Role | What they receive |
|---|---|---|
| Parkinson | 1. without gait impairment
2. with gait and/or balance impairment
3. with sleep disorders (RBD)
abnormalities of the brainstem and basal ganglia will be studied in relation with parkinsonism, gait and presence of RBD Receives: Other: 3T and 7T MR imaging | |
| PSP | supranuclear palsy patients study the abnormalities with the brainstem and basal ganglia and relation with the observed neurological signs (eye movements, balance, neuropsychological assessment and parkinsonism) Receives: Other: 3T and 7T MR imaging | |
| controls | age matched controls Receives: Other: 3T and 7T MR imaging |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2010 (estimated)
- Study start6 Apr 2010
- Primary completion26 Nov 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01085253
- Sponsor's protocol ID
- C09-15
- Other IDs
- 2009-A00922-55
- Acronym
- Nucleipark
- Status last verified
- Jan 2025
- First submitted
- 10 Mar 2010
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Field MR Imaging (7T and 3T) of the Brainstem, the Deep Nuclei and Their Connections in the Parkinsonian Syndromes. Applications to Prognosis, Pathophysiology and Improvement of Therapeutic Strategies
- ClinicalTrials.gov ID
- NCT01085253
- Acronym / sponsor ID
- Nucleipark / C09-15
- Conditions
- Parkinson's Disease, MRI
- Keywords
- Parkinson's, supranuclear palsy, substantia nigra, sub thalamic nucleus, MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Study start
- 6 Apr 2010 (actual)
- Primary completion
- 26 Nov 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 11 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To date except for the larger striato-pallidal complex, there are no reliable imaging markers of small deep nuclei. Major improvement of the spatial resolution resulting from the use of ultra-high field MRI systems offers new perspectives of imaging of these deep structures.
We will use the new contrast mechanisms available in data acquired with ultra-high field MR systems (7T) as well as the most recent high angular diffusion imaging techniques in order to characterize the cytoarchitectonics of the deep brain structures and brainstem lesions in parkinsonian syndromes (with special interest in substantia nigra (SN) pathology and nigro-striatal fiber pathways; subthalamic nucleus (STN), red nucleus (RN), oculomotor structures (involved in PSP); pedonculo-pontine nucleus (involved in gait and posture control disorders) and the locus sub-coeruleus area (implicated in sleep disorders) The optimized MR sequences at 7T will be adapted and validated at 3T (on a more clinically oriented MRI approach).
The clinical goal of the project (via the characterization of deep brain structures) is the detection of new neuroimaging markers of neuronal lesions in PD. These biomarkers will be used to create a diagnostic tool at early stage of the disease that could be correlated to clinical signs such as gait disorders and help to identify predictive factors. In addition, this could contribute to establish an adequate therapeutic strategy (as for example with deep brain stimulation).
Detailed description
This project will be divided into several methodological steps. First, we will establish an imaging protocol using high field MR systems (7T) to deliver high resolution data. The new T1/T2-star contrasts mechanisms observed in high field data will make possible the segmentation of the central structures, more specifically those deeply located in the brainstem, the pons and the mesencephalon that are involved in Parkinsonian syndromes. Second, we will characterize the cytarchitectony of the deep structures and the anatomical connectivity involved in the Parkinsonian syndromes using high angular resolution diffusion imaging (HARDI). The local information about the organization of the tissue coming from the HARDI data will be used to subdivide the deep structures into smaller nuclei. We will also use the HARDI data to infer the connectivity of these structures, employing probabilistic tractography algorithms more efficient to detect the smallest bundles. Such techniques have never been used for Parkinsonian syndrome, and may highlight structural differences inside deep nuclei that could not be observed when performing statistics on the entire structure. Third, preclinical studies will be performed in order to tackle the best spatial and angular resolutions and to build an atlas of the brainstem that will help understanding its structural organization. Clinical acquisitions will be done to acquire two databases of healthy volunteers and patients suffering from Parkinsons disease and progressive supranuclear palsy. Fourth, we will develop a statistical tool for isolating the biomarkers of the Parkinsonian syndrome and to create a diagnosis tool of the pathology, relying on robust bootstrapping techniques. The markers will stem from comparisons between populations using the various informations available. Expected results In this project, we will develop ultra high field techniques that will allow us to investigate the characteristics of the brainstem structures and of the central deep nuclei in normal subjects and in parkinsonian syndromes. The findings obtained with these image innovation techniques will help to overcome the present technical difficulties and limits of 1.5 and 3T MRI as some of the methods will be transferred to the routine machines and results will be compared to the images obtained on 3T MRI, in order to make new diagnosis tools available, in clinical research or clinical practice. The ultimate goal is to improve the accuracy of diagnosis of various parkinsonian syndromes at a early stage, to detect at a pre-clinical stage abnormalities that may reflect the underlying anatomical lesions, to improve the accuracy of neurosurgical targeting for deep brain stimulation, to detect imaging markers that may be useful biomarkers of the progression of the disease in neuroprotective therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson | – | Other: 3T and 7T MR imaging1. without gait impairment 2. with gait and/or balance impairment 3. with sleep disorders (RBD) abnormalities of the brainstem and basal ganglia will be studied in relation with parkinsonism, gait and presence of RBD |
| PSP | – | Other: 3T and 7T MR imagingsupranuclear palsy patients study the abnormalities with the brainstem and basal ganglia and relation with the observed neurological signs (eye movements, balance, neuropsychological assessment and parkinsonism) |
| controls | – | Other: 3T and 7T MR imagingage matched controls |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- parkinson's disease (PD) supranuclear palsy (PSP) controls
Key inclusion criteria (2 listed)
- PD according to the UK brain bank diagnosis criteria
- PSP according to the NINDS diagnosis criteria
Key exclusion criteria (1 listed)
- contra indication to MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3T and 7T MR imagingall patients and controls will be explored using a 3T and 7T MR imaging | Other | PSP, Parkinson, controls |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and MRI, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.